Analysis of Genotoxic Impurities

Article

Researchers from the Research Institute for Chromatography (Kortrijk, Belgium) and AstraZeneca R&D Charnwood (Loughborough, UK) used in-situ derivatization and liquid chromatography?mass spectrometry (LC?MS) to analyze arylamines and aminopyridines, which can be present as potentially genotoxic impurities in pharmaceutical preparations at trace levels.

Researchers from the Research Institute for Chromatography (Kortrijk, Belgium) and AstraZeneca R&D Charnwood (Loughborough, UK) used in-situ derivatization and liquid chromatography–mass spectrometry (LC–MS) to analyze arylamines and aminopyridines, which can be present as potentially genotoxic impurities in pharmaceutical preparations at trace levels. The method included a derivatization procedure using hexylchloroformate followed by reversed-phase LC with single-quadrupole MS in the selected ion monitoring mode. They found that the derivatized compounds exhibited better chromatographic behavior.

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Angela I. Calderón is a Gilliland Endowed Professor in the Department of Drug Discovery and Development, Harrison College of Pharmacy, Auburn University. She received her B.S. in Pharmacy from the University of Panama, Panama City, Republic of Panama (1990), MSc. in Pharmacognosy from the University of Illinois at Chicago, Chicago, Illinois under the supervision of Dr. Djaja Djendoel Soejarto and Dr. Cindy K. Angerhofer (1997), and Ph.D. in Pharmacognosy from the University of Lausanne, Lausanne, Switzerland under the guidance of Prof. Kurt Hostettmann (2002). Then, she conducted her postdoctorate on biomedical applications of mass spectrometry at Prof. Richard B. van Breemen’s laboratory at the University of Illinois at Chicago (2006-2008). She joined the faculty at Auburn University College of Pharmacy as an Assistant Professor in August 2008. Dr. Calderón specializes in natural drug products research, specifically applications of mass spectrometry to natural products drug discovery, and quality and safety assessment of botanical dietary supplements. Over the last sixteen years, she has authored 52 publications, 1 US patent, and 5 book chapters. She also has received research funding from agencies that include National Center for Complementary and Integrative Health (NCCIH) and the Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH), American Society of Pharmacognosy, United States Pharmacopeia, Auburn University Research Initiative in Cancer (AURIC), and botanical dietary supplements industry. Dr. Calderón is currently an expert member of the United States Pharmacopeia Botanical Pan-American Expert Panel. She also was a member of the United States Pharmacopeia Botanical Dietary Supplements and Herbal Medicines Expert Committee. Additionally, she was the Section Editor of Pharmacognosy of Combinatorial Chemistry & High Throughput Screening and Pharmaceutical Biology and is a current member of the Advisory Board of Planta Medica She has been grant proposal reviewer for National Institutes of Health (NIH), National Science Foundation (NSF), USA and German Federal Ministry of Education and Research (BMBF) and Project Management Jülich (PtJ) and Deutsche Forschungsgemeinschaft (German Research Foundation), Germany, and International Foundation for Science (IFS), Sweeden.

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